There are 2 potential treatment strategies for patients with newly diagnosed advanced ovarian cancer, explained Neil Horowitz, MD: primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS). Choosing between the 2, he added, can be a challenge.

If a surgeon decides to proceed with primary debulking, they should be confident that they can achieve no gross residual disease. However, if a patient presents with stage IV disease, liver involvement, bulky disease in the chest, or unresectable disease, they could be candidates for neoadjuvant NACT-IDS.

The ongoing TRUST trial (NCT02828618) was designed to compare these 2 approaches in an attempt to better define the surgical standard for patients, added Horowitz. The trial will randomize patients to undergo cytoreduction followed by 6 cycles of standard chemotherapy or 3 cycles of standard neoadjuvant chemotherapy followed by interval debulking surgery and another 3 cycles of standard chemotherapy. Primary results from the trial are expected in April 2023.

“In order to enroll patients on the trial you have to do a certain volume of surgery,” said Horowitz. “You have to show proficiency in the surgeries that are required to get down to no gross residual disease. You have to submit a video of your surgery. There are panels that judge whether it’s an appropriate, high-level surgery or one that can't participate.”

By standardizing the surgeons and their surgical ability, he added, the question of whether there is equivalency between primary debulking surgery and neoadjuvant chemotherapy may finally be answered.

In an interview during the 2018 OncLive® State of the Science Summit™ on Ovarian Cancer, Horowitz, director of Clinical Research in Gynecologic Oncology, associate professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Dana-Farber Cancer Institute, discussed surgical options for patients with newly diagnosed ovarian cancer.

OncLive: What is the role of cytoreductive surgery for these patients?

Horowitz: The basis of my presentation [at the State of the Science SummitTM] was the role of cytoreductive surgery in the upfront management of ovarian cancer. We looked at historical data with regard to surgery. Additionally, work from Joseph Meigs, MD, showed that the amount of residual disease is a predictor of long-term outcomes for women with ovarian cancer. Following those data, we tried to define what optimal cytoreduction is and how that definition has changed over time—how it evolved from less than 2 cm to what we believe should be no gross residual disease.

We also compared the outcomes from primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreduction. In addition, we discussed ways to predict which women may be best suited for upfront surgery versus neoadjuvant chemotherapy.

If a patient presents with advanced disease, how does that impact their surgical options?

Trying to decide which women should undergo primary cytoreductive surgery is a challenge. There is no standard predictive model, whether radiographic or in terms of CA125 values. There are certain disease locations that can be determined by imaging as “no-fly zones.”